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Hemodynamic Measurements During Liver Transplantation (OLT)

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ClinicalTrials.gov Identifier: NCT00682110
Recruitment Status : Completed
First Posted : May 22, 2008
Last Update Posted : April 1, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of the study is to determine if the less invasive monitors are as reliable for measuring heart function in patients undergoing liver transplantation as the more invasive pulmonary artery.

Condition or disease
Liver Transplantation

Detailed Description:
Pulmonary artery catheter (PAC)is considered the gold standard in monitoring of heart function during orthotopic liver transplantation (OLT). Placement of PAC is very invasive (it passes thorough the heart chambers and into the pulmonary artery) and its benefits on the outcomes have not been proven. This study compares two newer FDA approved much less invasive devices to the PAC. The two new devices assess the heart function based either on the peripheral arterial waveform alone (Vigileo, Edwards Lifesciences)or the combination of peripheral arterial waveform and chemical indicator dilution (LiDCO, Cambridge, UK).

Study Design

Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Comparing Different Methods For Measurement of Cardiac Output During Orthotopic Liver Transplantation
Study Start Date : July 2007
Primary Completion Date : January 2009
Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Agreement between cardiac output measurements obtained with PAC, Vigileo and LiDCO [ Time Frame: Specific phases of liver transplantation surgery ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
20 subjects will be enrolled in this observational study in the Liver Transplant Group; 10 patients in the Other Surgery Control Group for a total of 30 subjects. Patients will be recruited from the Operating Room schedule. Written, informed consent will be obtained from each subject prior to surgery. All participants will be informed that they may decline to participate in, or withdraw from, the study at any time.
Criteria

Inclusion Criteria:

  • Patients over 18 years of age
  • Scheduled for liver transplantation
  • Patient undergoing vascular surgery where invasive arterial pressure is indicated (control subjects)

Exclusion Criteria:

  • We will exclude patients taking lithium based medication
  • Patients who weigh less than 40 kg; AND
  • Patients who are pregnant
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00682110


Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Ivan Kangrga, MD, PhD Washington University School of Medicine